3SBio Inc. and Isotechnika Pharma Inc. have announced the signing of a development and commercialization agreement for voclosporin, a next generation calcineurin inhibitor being developed for use in the prevention of organ rejection following transplantation and the treatment of autoimmune diseases. 3SBio will be responsible for the clinical development, registration and commercialization of voclosporin in China. Isotechnika will provide, under separate agreement, commercial supply to 3SBio on a cost-plus basis.

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NephRx Corporation announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to its lead product NX001 for the prevention of delayed graft function (DGF) in renal transplant recipients. NX001 is a kidney growth factor peptide that has demonstrated good safety and promising efficacy in two animal models of acute renal failure. DGF affects an estimated 20-25% of the approximately 14,000 renal transplants performed annually in the U.S.

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Siemens Healthcare announces FDA clearance for the UROSKOP® Omnia, its new multifunctional workstation for urology. The workstation’s new dynamic flat detector technology UROSKOP Omnia allows the urologist to cover the entire urinary tract – kidney, ureter, bladder (KUB) – with only one single exposure and in superb image quality. With its curved X-ray column, UROSKOP Omnia offers truly unrestricted patient access from all table sides.

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Claros Diagnostics has announced the CE Mark approval for its rapid quantitative point-of-care diagnostic platform, which can now be used for prostate specific antigen (PSA) testing throughout the European Union. The approved system consists of a small portable analyzer and credit card-sized disposable. Claros is preparing for the European launch of its urology product and continuing the process to attain regulatory clearance in other markets, including the U.S.

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Sorafenib therapy is safe and effective, with evidence of long-lasting disease control in elderly patients with metastatic renal cell carcinoma (mRCC), according to research presented at the 2nd European Multidisciplinary Meeting on Urological Cancers (EMUC). On the basis of increasing incidence of RCC with age, the objective of this retrospective, subset analysis was to assess the safety and efficacy of sorafenib in patients older than 65 years of age.

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Repros Therapeutics has announced that the Company has entered into an amendment with the National Institutes of Health (NIH) to its existing exclusive license for Proellex® that revises the existing milestones and dates for performance to provide additional time to lift the current clinical hold on Proellex or select a second generation molecule for further development from the family of anti-progestational agents covered by the license.

A new study has indicated that endometriosis, in which cells from the lining of the uterus grow in other regions such as fallopian tubes and ovaries, can also be quickly and accurately identified by a small test. Researchers led by Ian Fraser at the University of Sydney and Maomar al-Jefout of Mu’tah University found that a small tissue sample taken from the uterine lining with a device inserted through the vagina works just as well. This condition of the uterus, which is linked to infertility, painful periods and pain during sexual intercourse, until now could only be detected through surgery.

Novadaq Technologies Inc, a developer of real-time imaging systems used in the operating room, announced that its SPY endoscopic imaging system has received 510(k) clearance from the US Food and Drug Administration for use during minimally invasive surgery (MIS). Novadaq’s SPY “scope” combines the traditional features of a state of the art, high definition standard endoscope with the fluorescence capabilities of the SPY imaging system, which is currently used in a variety of open surgical procedures.

Researchers at the University of Minnesota are closer to developing a simple urine test to identify smokers who are at high risk of developing lung cancer. Although the test is still years away, the hope is to spot high-risk people earlier when there is still time to prevent or treat the cancer, says Jian-Min Yuan, MD, associate professor of cancer epidemiology at the University.

Researchers have reported the successful performance of renal cryotherapy, wedge biopsy of a kidney, abdominal sacrocolpopexy, and radical nephrectomy using the Uni-X Single Port Access Laparoscopic System of Pnavel Systems, New Jersey. The Uni-X Single Port is placed through a 1.5cm incision in the body. There are three portals in the port for the passage of a 5mm flexible steerable laparoscopic endoscope and 2, 5 mm articulating instruments. The endoscope and instruments can be triangulated at the broader angles.